The present disclosure generally relates to an analysis system and method for determining an analyte in a body fluid and, in particular, to relates analysis system and method for determining an analyte in a body fluid comprising a reusable analysis instrument and a magazine having a plurality of integrated sample acquisition and analyzing elements.
To determine an analyte in a body fluid for diagnostic purposes, typically, small quantities of the fluid are taken from a body part. Frequently, blood is analyzed as a body fluid for this purpose. Puncturing devices having a lancet are used for the purpose of generating a wound in a body part, such as, for example, the fingertip or the earlobe. Puncturing devices of this type are implemented in such a manner that they can be used not only by medical personnel, but also by medical laypersons.
In general, a plurality of steps must be performed to determine an analyte in the body fluid. Firstly, a wound must be generated in the body part, from which a body fluid can exit. The body fluid is analyzed using a measuring unit. Typically, this can be performed using two devices operating independently from one another. The use of two devices is quite uncomfortable for the user. Therefore, combined systems are frequently used, which both generate the wound as well as analyze the exiting fluid.
In addition, to simple operation and increased operating comfort, a compact design of the devices can be important. In addition, piercing which is as pain-free as possible is a goal. This increases the acceptance of devices of this type for diabetics in particular, who have to determine the glucose content in their blood a plurality of times a day.
An integrated analysis instrument having a test sensor and a lancet is known, for example, from WO 2006/092281, which determines an analyte in a body fluid by electrochemical measurement. A capillary channel is provided in a test strip, via which a received body fluid is transferred to test electrodes, to determine an analyte by means of a measuring unit. The lancet is located on the bottom side of the test strip. The lancet is movable in relation to the test strip and is enclosed by a sterile envelope, from which it exits before piercing into the body part. The body fluid exiting from the wound is suctioned in by the capillary channel on the top side of the test strip and conducted to the electrodes of the electrochemical measuring unit. Because of the coupling mechanism of the analysis instrument to the integrated test sensor, the instrument is used with individual test sensors. Locating a plurality of disposable test sensors in a magazine is not provided.
To avoid complex use of individual integrated puncture and analyzing elements, analysis systems are known in which the puncture and analysis elements are stored in a magazine. Such a system is described, for example, in US 2003/0212345. The puncture and analyzing element used comprises a needle having a capillary channel, which is molded onto an analyzing element. Blood acquired during piercing is conducted through the capillary channel to the test zone of the puncture and analyzing element, which is implemented in one piece. The used elements are stored in a separate magazine or ejected from the system after use.
A plurality of systems are known in the prior art, in which integrated sensors having a puncturing element and an analyzing element are located in a magazine. U.S. Pat. No. 6,607,658, EP 1402818, and US 2002/0052618 disclose sensors of this type, for example. However, the sensors have to be completely removed from the magazine to be able to perform their function. This requires a relatively large construction of the analysis instruments.
An analysis system having an integrated puncture and analyzing element which is stored in a magazine is disclosed in US 2003/0143113. The puncture and analyzing element is not completely removed from the magazine, which simplifies the automated handling in the analysis system, in particular if the puncture and analysis system is moved back in the magazine after use. Because the puncture and analyzing element is implemented in one piece, the test zone of the analyzing element is also subjected to a sterilization of the puncturing element, so that the analysis capability of the test zone is reduced.
Therefore, there is a need for a compact analysis system in which a plurality of integrated sample acquisition and analyzing elements are stored.